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Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma

This study has been completed.

Sponsored by: Metabasis Therapeutics, Inc.
Information provided by: Metabasis Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00073736
  Purpose

Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for this study is to determine the safety and tolerability of MB07133.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: MB07133
Phase I
Phase II

MedlinePlus related topics:   Cancer    Liver Cancer   

Drug Information available for:   MB-07133   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:   A Phase 1/2 Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MB07133 in Subjects With Unresectable Hepatocellular Carcinoma and Child-Pugh Class A Liver Function

Further study details as provided by Metabasis Therapeutics, Inc.:

Primary Outcome Measures:
  • Safety and tolerability

Secondary Outcome Measures:
  • Determine effect of MB07133 on tumor size

Estimated Enrollment:   36
Study Start Date:   September 2003
Primary Completion Date:   July 2007 (Final data collection date for primary outcome measure)

Detailed Description:

To determine the maximum tolerated dose of MB07133 when administered as a 7-day continuous i.v. To characterize the safety profile and the pharmacokinetics of MB07133 and metabolites during and after continuous infusion. To determine the effect of MB07133 on hepatocellular carcinoma (HCC) tumor size.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with a diagnosis of local unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. "Local" is defined as disease either restricted to the liver or contiguous with the liver and no identifiable extrahepatic disease.
  • Patients with Child-Pugh Class A liver function. For purposes of this trial, an eligible patient must not have Encephalopathy or Ascites and the total Child-Pugh score cannot be greater than 6 at baseline
  • Males or females 18 years of age or older
  • Ability to provide written informed consent before initiation of any study-related procedures and ability, in the opinion of the Principal Investigator, to comply with all the requirements of the study
  • Male and female subjects who are surgically sterile, who remain abstinent, or who agree to practice double barrier forms of birth control from screening through 30 days (females) and 90 days (males), from the last dose of study medication

Exclusion Criteria:

  • History of or presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, GI, pulmonary, immunological (with the exception of the presence of hepatitis B virus [HBV], HCV hepatitis, or cirrhosis), endocrine, or central nervous system disorders
  • Patient has a history of cancer other than hepatocellular (excluding resected basal cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for 5 years or more).
  • Patients with distant metastasis or extrahepatic disease
  • An Eastern Cooperative Oncology Group (ECOG) performance status score of greater than or equal to 2
  • Current encephalopathy or current treatment for encephalopathy
  • History of drug or alcohol abuse within 6 months before screening
  • History of, or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent
  • A documented variceal hemorrhage within 4 months of screening
  • Neutrophil count less than or equal to 1,500/mm3, platelet count less than or equal to 100,000/mm3, hemoglobin less than or equal to 8.5 g/dL, or a Prothrombin Time (INR) greater than 1.3 (vitamin K supplementation allowed)
  • Serum creatinine greater than 1.1 times the upper limit of normal
  • History of human immunodeficiency virus or acquired immune deficiency syndrome
  • Use of an investigational drug or product or participation in a drug study within 30 days before dosing
  • Liver function defined as: serum bilirubin greater than 1.5 times the upper limit of normal or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, or serum albumin less than 3.2 g/dL
  • History of gout or abnormal uric acid metabolism
  • The clinical presence of ascites
  • Treatment of HCC within 30 days of screening by chemotherapy or treatment of the target lesion(s) by chemoembolization, PEI, or surgery
  • Radiofrequency ("RF") ablation of the target lesion(s) within 60 days of screening
  • Subjects with a life expectancy of less than 12 weeks
  • Subjects having received an organ transplant
  • Subjects currently receiving coumadin or heparin
  • Pregnant or nursing women
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073736

Locations
United States, California
University of California at Irvine    
      Orange, California, United States, 92868
Hong Kong
Prince of Wales Hospital - Comprehensive Cancer Trial Unit    
      Shatin, New Territories, Hong Kong
Taiwan, Nei Hu District
Tri-Services General Hospital    
      Taipei, Nei Hu District, Taiwan, 114
Taiwan, Taoyuan County
Chang-Gung Memorial Hospital    
      Taipei, Taoyuan County, Taiwan, 333

Sponsors and Collaborators
Metabasis Therapeutics, Inc.

Investigators
Study Director:     Isabela Niculae, MPH     Metabasis Therapeutics, Inc.    
  More Information


Responsible Party:   Metabasis Therapeutics, Inc. ( Howard Foyt, MD/VP, Clinical Development )
Study ID Numbers:   HCC-101
First Received:   December 3, 2003
Last Updated:   February 12, 2008
ClinicalTrials.gov Identifier:   NCT00073736
Health Authority:   United States: Food and Drug Administration

Keywords provided by Metabasis Therapeutics, Inc.:
Hepatocellular  
Carcinoma  
Liver  
Cancer  

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008




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